DETAILED ANSWERS|LATEST UPDATE!!!!!!2026|GUARANTEED
CORRECT = 100
100
INCORRECT=0
STUDY MATERIALS.......DESIGNED TO HELP YOU SUCCEED
SPOTLIGHT 1
1
, WELL DETAILED ANSWERS|LATEST
UPDATE!!!!!!2026|GUARANTEED PASS|GRADED
Which of the following is a disclosure of financial interests form? - ANSWER FDA
Form 3455
Which of the following is a certification of financial interest form? - ANSWER FDA
Form 3454
If the investigator did have financial arrangement with the sponsor, he/she would submit the
following form: - ANSWER FDA Form 3455
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial -
ANSWER Investigational New Drug Application (1571)
In the top right corner, form have OMB number. What does it stand for? -
ANSWER Office of Management and Budget
The form, which is submitted to the FDA to report an Adverse Event is -
ANSWER 3500
Medical device adverse events/problems are reported via a form: - ANSWER 3500A
What is FDA form 1571? - ANSWER Cover-sheet for Investigational New Drug
Applications
2
, 21 CFR 312 deals with - ANSWER Investigational New Drug Application
Investigational new drug means - ANSWER A new drug or biological drug that is
used in a clinical investigation
The immediate package of an investigational new drug intended for human use shall bear a
label with the statement - ANSWER "Caution: New Drug—Limited by Federal (or
United States) law to investigational use."
Which of the following is not listed on FDA form 1571: - ANSWER Approved
informed consent document
"Any adverse drug experience that places the patient or subject, in the view of the
investigator, at immediate risk of death from the reaction as it occurred" Is... -
ANSWER Life threatening adverse drug experience
What are the three main basic ethical principles of the Belmont Report? -
ANSWER 1. Respect for Persons
2. Beneficence
3. Justice
What are the applications for the Belmont Report? - ANSWER 1. Informed Consent
2. Assessment of Risk and Benefits
3. Selection of Subjects
What phrase of a drug trial usually includes hundreds to thousands of volunteers? -
ANSWER Phase 3: These studies gather more information about safety and
effectiveness, study different populations and different dosages, and uses the drug in
combination with other drugs.
3
CORRECT = 100
100
INCORRECT=0
STUDY MATERIALS.......DESIGNED TO HELP YOU SUCCEED
SPOTLIGHT 1
1
, WELL DETAILED ANSWERS|LATEST
UPDATE!!!!!!2026|GUARANTEED PASS|GRADED
Which of the following is a disclosure of financial interests form? - ANSWER FDA
Form 3455
Which of the following is a certification of financial interest form? - ANSWER FDA
Form 3454
If the investigator did have financial arrangement with the sponsor, he/she would submit the
following form: - ANSWER FDA Form 3455
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial -
ANSWER Investigational New Drug Application (1571)
In the top right corner, form have OMB number. What does it stand for? -
ANSWER Office of Management and Budget
The form, which is submitted to the FDA to report an Adverse Event is -
ANSWER 3500
Medical device adverse events/problems are reported via a form: - ANSWER 3500A
What is FDA form 1571? - ANSWER Cover-sheet for Investigational New Drug
Applications
2
, 21 CFR 312 deals with - ANSWER Investigational New Drug Application
Investigational new drug means - ANSWER A new drug or biological drug that is
used in a clinical investigation
The immediate package of an investigational new drug intended for human use shall bear a
label with the statement - ANSWER "Caution: New Drug—Limited by Federal (or
United States) law to investigational use."
Which of the following is not listed on FDA form 1571: - ANSWER Approved
informed consent document
"Any adverse drug experience that places the patient or subject, in the view of the
investigator, at immediate risk of death from the reaction as it occurred" Is... -
ANSWER Life threatening adverse drug experience
What are the three main basic ethical principles of the Belmont Report? -
ANSWER 1. Respect for Persons
2. Beneficence
3. Justice
What are the applications for the Belmont Report? - ANSWER 1. Informed Consent
2. Assessment of Risk and Benefits
3. Selection of Subjects
What phrase of a drug trial usually includes hundreds to thousands of volunteers? -
ANSWER Phase 3: These studies gather more information about safety and
effectiveness, study different populations and different dosages, and uses the drug in
combination with other drugs.
3
